• The Journal of Korean Medicine
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• v.40 no.1
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

• Quality Improvement in Health Care
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• v.27 no.1
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• pp.20-25
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• 2021

Purpose: The ability to access clinical trials for cancer treatment is important. This study investigated whether regional differences exist in oncologic clinical trial protocols conducted in South Korea. Methods: Records of all approved oncologic clinical trials conducted in 2019 were downloaded from the Republic of Korea Ministry of Food and Drug Safety. The study covered Seoul, the capital area, other metropolitan cities, and provincial areas. Descriptive statistics summarized the distribution patterns of clinical trials by region. Results: A total of 202 oncologic clinical trials were conducted in 63 institutions in 2019. Of these protocols, 186 (92%) were available in Seoul, 120 (59%) in the capital area, 64 (32%) in metropolitan cities, and 66 (33%) in provincial areas. More regional differences in protocol availability were observed in domestic trials, investigator-initiated trials, phase 1 and 2 trials, and smaller-scale trials. Conclusion: Most oncologic clinical trials were conducted in medical institutions located in Seoul, with the rest conducted in the capital area, metropolitan cities, and provincial areas. The findings reveal clear differences in protocol availability between Seoul and the other regions. Measures designed to improve geographical access to oncologic clinical trials may be needed given their growing importance in cancer treatment.

• Journal of Acupuncture Research
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• v.23 no.1
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• pp.165-177
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• 2006

Objectives : 1. Clinical trial for the efficacy evaluation of Korean acupuncture techniques in treating frozen shoulder. 2. Development of the standard clinical guidelines of the acupuncture treatment for the frozen shoulder. 3. Development of the new clinical protocol for the acupuncture treatments. 4. Verification of the hypothesis that treating at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints. Methods : 1. Research designed as Single blind, Randomized, Sham acupuncture controlled clinical Trial. 2. Assignment of 86 patients to one of three groups treated at nearby acupoints(group A), remote & nearby acupoints(group B), and sham points(group C) respectively. 3. Trial conducted at KIOM CRC of Dunsan oriental medical hospital, Daejeon Univ. 4. Estimation of the recovery rate of the frozen shoulder in subjects aged over 40. 5. Efficacy evaluation using VAS, SPADI, ROM and Improvement rate. Results : 1. There was no significant difference in VAS among the three groups. 2. Pain related scores in SPADI of the group B were significantly lower than those of the group A. 3. There was no significant difference in disability related scores of SPADI among the three groups. 4. External rotation of upper arm in the group B was significantly improved in comparison with that in the group C. 5. Abduction of upper arm in group A was improved with weak statistical significance in comparison with that in the group C. Conclusion : Acupuncture at both the remote and the nearby acupoints according to the meridian theory is effective to improve external rotation of frozen shoulder, and acupuncture at the nearby acupoints is effective to improve adduction of frozen shoulder. However it is not clear that acupuncture treatment at both the remote and the nearby acupoints according to the meridian theory is more effective than treating at only the nearby acupoints in the treatment of frozen shoulder. Since our study was a short term trial, a long term trial for a more precise evaluation of acupuncture treatment for frozen shoulder will be needed in the future.

• Korean Journal of Acupuncture
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• v.26 no.4
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• pp.53-66
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• 2009

Objective : Acupuncture has been widely used throughout the world for the treatment of knee osteoarthritis (knee OA). This study investigated whether acupuncture, particularly Sa-am acupuncture, could be effective in relieving pain and improving the symptoms of knee OA. Method : This study was conducted as a prospective, randomized, controlled, and patient- and investigator-blinded clinical trial. Forty volunteers with knee OA participated in the study. All participants were screened through an inclusion and exclusion criteria. Thirty four participants completed the clinical trial. In total, forty subjects were randomly selected to receive Sa-am acupuncture. Eight sessions of acupuncture were given at the contralateral side of the problematic knee for 4 weeks. Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index (KWOMAC) scores were measured twice: at the beginning and end of the clinical trial period. Both the Patient Global Assessment and physical health scores based on the 36-Item Short-Form Health Survey were also used to measure the results. Results : Compared to the pre-trial scores, the Sa-am acupuncture group (n=34) showed a significant decrease in KWOMAC total scores according to a paired t-test. The Sa-am acupuncture group also showed significant improvement in the Patient Global Assessment when compared to the pre-trial. Conclusions : Sa-am acupuncture for knee OA resulted in an improved KWOMAC total score. This was mostly driven by the function component score that was greatly affected by acupuncture. However, further studies with expanded designs are needed to solidify this finding with scientific rigor.

• Clinical Nutrition Research
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• v.13 no.1
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• pp.22-32
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• 2024

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disorder with widespread synovitis. Isoflavones, the main active component of soy, have been reported to have potent anti-inflammatory effects; the previous RA animal models showed the promising effect of soy supplementation. We aimed to evaluate the effect of soy bread on inflammatory markers and lipid profiles in RA patients. The present study was designed as a randomized controlled trial. RA patients were randomly allocated to obtain soy bread (n = 22) or placebo bread (n = 22) for 8 weeks. Fasting serum levels of lipid profile, total antioxidant capacity (TAC), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and DAS28 were checked. Findings showed that there were no significant differences between the two groups in physical activity and dietary intake at the beginning of the study and the end of the study. There were no significant differences between the two groups in measured lipid profile markers, including high-density lipoprotein, low-density lipoprotein, total cholesterol, triglyceride, and very low-density lipoprotein, at the end of the trial. In addition, TAC and CRP also were not significant at the end of the trial between the 2 groups (0.66 and 0.12, respectively). However, the serum levels of TNF-α reduced significantly in the soy bread group at the end of the intervention (p < 0.000) and compared with the control group (p < 0.019). Soy bread consumption only decreased circulating TNF-α serum concentration. Other outcome measures were not changed following supplementation. Future long-term, well-designed studies are needed to confirm these findings.

• The Journal of Internal Korean Medicine
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• v.37 no.1
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• pp.109-134
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• 2016

Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

• Journal of The Korean Society of Integrative Medicine
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• v.10 no.3
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• pp.27-36
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• 2022

Purpose : This study was aimed to analyze the effects of cosmetics containing Persicaria perfoliata water extract (PPWE) on the skin moisturizing and improvement of skin condition in clinical trials. Methods : Clinical trial was conducted for five weeks after IRB approval at Dong-Eui University. Out of a total of 64 people, 15 people each were assigned to four groups as follows; control group A, B, C and the experimental group A that using cosmetic containing PPWE. Skin condition was measured two times, before and after clinical trial, by a professional skin analyzer, SDM (skin diagnosis system). Moisture and oil value of participants was analyzed twice, each morning and evening, using a portable device on their cheeks. In addition, the survey was investigated subjective satisfaction on change in skin condition and the satisfaction on the use of cosmetics. Result : The experimental group exhibited subjectively significant changes before and after clinical trials on skin its dryness (p=.039), blush (p=.017), and redness (p<.001). In addition, subjective evaluation was also the highest satisfaction in aspects of number of application (p=.003), amount of application (p=.002), moisture maintenance, and skin scratching frequency. The satisfaction on the use of cosmetics was the highest in the intention to repurchase (p=.045), recommendation willingness to others (p=.020), and intention to use various products (p=.001). Skin moisture of the clinical trial participants using the SDM, moisture level and elasticity of the experimental group increased by 12.94 and 10.28. Moisture level, which was measured by a portable device, was the most potently increased in the experimental group. Conclusion : Consequently, PPWE containg cosmetics exhibited the effects of moisturization and attenuated skin dryness in clinical trials, which might be utilized as a fundamental data to develop numerous lines of cosmetics.

• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.74-83
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• 1994

• The Korean Journal of Applied Statistics
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• v.27 no.1
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• pp.13-20
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• 2014

Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.